Comparison of short and long term complications of treatment with oral ibuprofen versus fluid restriction in preterm infants with patent ductus arteriosus .

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2013071113022N2

Enrollment

Registered

2013-08-04

Start date

2013-01-01

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patent Ductus Arteriosus. Patent ductus arteriosus

Interventions

Intervention 1: In the intervention group 3 doses of oral ibuprofen were prescribed with the dose of 5mg/kg on the first day and 10 mg/kg at 24 and 48 hours after the first dose. Intervention 2: The

Treatment - Drugs

Treatment - Other

In the intervention group 3 doses of oral ibuprofen were prescribed with the dose of 5mg/kg on the first day and 10 mg/kg at 24 and 48 hours after the first dose.

The control group only received fluid restriction at the dose of 2/3 of maintenance dose required individually.

Eligibility

Sex/Gender

All

Age

No minimum to 1 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: All premature neonates with gestational age of less than 38 weeks:EKG with left axis deviation of prematurity:the neonates of having systolic murmur and bounding pulse .and the neonates with patent ductus arteriosus proved on echocardiography were included. Exclusion criteria: Those having other congenital heart disease than PDA:neonates with other congenital anomalies:neonates with clinical signs of congestive heart failure :the neonates of mothers taking nonsteroidal antiinflammatory agents during pregnancy

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Ductal Closure. Timepoint: First day-3rd day-3rd month-6 months. Method of measurement: Echocardiography.;Pulmonary hypertension. Timepoint: 1st day-3rd day-3rd month-6th month. Method of measurement: Echocardiography.	—

Secondary

Measure	Time frame
Intraventricular hemorrhage. Timepoint: 1st week-1st month. Method of measurement: sonography.;Periventricular leukomalacia. Timepoint: 1st week-1st month. Method of measurement: sonography.;Retinopathy of prematuriity. Timepoint: At discharge. Method of measurement: Retinoscope.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSemira Mehralizadeh MD

Semnan University of Medical Sciences

mehralizadehmd@yahoo.com,mehraliz@sem-ums.ac.ir+98 23 1446 0055

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026